Parotid Diseases Clinical Trial
Official title:
Evaluation of Safety and Effectiveness of the FMwand Ferromagnetic Surgical System During Parotidectomy Surgery
| Verified date | January 2016 |
| Source | Domain Surgical, Inc. |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Italy: Ethics Committee |
| Study type | Observational |
The objective of the clinical trial is to determine the suitability of the FMwand Ferromagnetic Surgical System for parotidectomy and Head & Neck surgery.
| Status | Completed |
| Enrollment | 5 |
| Est. completion date | December 2015 |
| Est. primary completion date | December 2015 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria: - Patients with an indication for surgical intervention for a parotidectomy. - ECOG status = 2. - Life expectancy > 3 months. - Age = 18 years old. - Able to provide written informed consent and EU Data Protection Directive forms prior to admission to this study. - Willingness to meet all of the expected requirements of this clinical protocol. Exclusion Criteria: - Age < 18 years old. - Pregnant or breastfeeding. - Vulnerable patient populations (homeless patients, patients with drug or alcohol dependence, etc.). - Concomitant treatments that would affect clotting, post-operative healing, increased chances of infection. - Previous radiation treatment - Previous head or neck surgery |
Observational Model: Case-Only, Time Perspective: Prospective
| Country | Name | City | State |
|---|---|---|---|
| Italy | San Camillo-Forlanini Hospital | Roma |
| Lead Sponsor | Collaborator |
|---|---|
| Domain Surgical, Inc. |
Italy,
Bowers CA, Burns G, Salzman KL, McGill LD, Macdonald JD. Comparison of tissue effects in rabbit muscle of surgical dissection devices. Int J Surg. 2014;12(3):219-23. doi: 10.1016/j.ijsu.2013.12.014. Epub 2014 Jan 7. — View Citation
MacDonald JD, Bowers CA, Chin SS, Burns G. Comparison of the effects of surgical dissection devices on the rabbit liver. Surg Today. 2014 Jun;44(6):1116-22. doi: 10.1007/s00595-013-0712-4. Epub 2013 Sep 5. — View Citation
Tok, S et al. Comparison of a Novel Thermal Surgical Technology with Monopolar and Carbon Dioxide Laser in a Rat Glioma Model. Poster presentation.
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Intraoperative Serious Adverse Events as a Measure of Safety and Feasibility | Safety and feasibility will be assessed by evaluating intra-operative serious adverse events, if any, and their relationship with the FMwand Ferromagnetic Surgical System. | 1 day after surgery | Yes |
| Secondary | Post-operative drainiage | Evaluation of Post-operative Drainage | Beginning day 2 after surgery and for the duration of hospital stay, an expected average of 6 days | No |
| Secondary | Swelling of surgical wound | Evaluation of surgical wound appearance based on swelling | Beginning day 2 after surgery and for the duration of hospital stay, an expected average of 6 days | No |
| Secondary | Necrosis of surgical margins | Serosity and necrosis of margins | Beginning day 2 after surgery and for the duration of hospital stay, an expected average of 6 days | No |
| Secondary | Length of hospital stay | Number of days (post-operative) of hospital stay | Beginning day 2 after surgery and for the duration of hospital stay, an expected average of 6 days | No |